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Pain is a frequent symptom in the intensive care unit (ICU). Critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible.
Pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry.
Several studies in ICU showed a significant relationship between pupillary diameter variation and pain.
The nociception level index (NOL-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room.
The aim of this study is to evaluate the pupillometry and NOL index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)
Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception level index (NOL-index).
The evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures.
The procedures are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pupillometry | Experimental | Pain will be evaluated via pupillometry with 3 successive measurements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic pain assessment | Other | Pain will be evaluated via i) pupillometry with 3 successive measurements ii) Behaviour Pain Scale (BPS) and Critical Care Pain Observation Tool (CPOT) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) Nociception Level Index (NOL) index. |
| Measure | Description | Time Frame |
|---|---|---|
| pupillary redilatation velocity after constriction light-induced | Area under the ROC curve (AUC) of pupillary re-dilation velocity measured before a potentially painful procedure to predict the occurrence of a BPS score ≥ 5 during the procedure. | 1 hour during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Nociception Level index | To evaluate the predictive value of the NOL-index measured before a potentially painful procedure to predict the intensity of the pain felt during the procedure. | 1 hour during procedure |
| Systolic and diastolic Blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai Anh NAY, MD | Regional Hospital Center of ORLEANS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Center | Orléans | 45067 | France | |||
| Universitary Hospital Center |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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|
Describe the variations of vital parameters
| 1 hour during procedure |
| Heart rate | Describe the variations of vital parameters | 1 hour during procedure |
| Respiratory rate | Describe the variations of vital parameters | 1 hour during procedure |
| Behaviour Pain Scale | Compare variations of nociception parameters during mobilizations and during tracheal aspirations Behaviour Pain Scale Score from 3 (no pain) to 12 (maximum pain) | 1 hour during procedure |
| Tours |
| 37000 |
| France |
| D012816 | Signs and Symptoms |